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Aspirin in the Treatment of Pregnant Women With Adenomyosis on Reducing Preterm Delivery

NCT04535804 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 550

Last updated 2020-09-02

No results posted yet for this study

Summary

Objective: This study intends to carry out a randomized double-blind clinical trial study of aspirin in the treatment of pregnancy with adenomyosis to reduce the incidence of preterm delivery, and provide a new therapeutic target for the prevention and treatment of premature birth and adverse pregnancy outcomes, and fill in the blank of effective prevention of premature delivery in pregnancy with adenomyosis at home and abroad Application value and social and economic benefits of the bed.

Methods: a randomized double-blind clinical trial was used in this study. In Shanghai first maternal and child health care hospital, the pregnant women who meet the requirements of the group will be given full informed consent. By using a random, double-blind research method, 1-550 digital computers are randomly divided into two groups, with two groups of digital coding placebo and aspirin. From 12 weeks of gestation, 100 mg of placebo or low-dose aspirin was given orally (2 tablets a time, twice a day, before going to bed) to 36 weeks of gestation.

Observe the outcome ① Main outcome measures: preterm delivery: delivery less than 37 weeks gestational weeks, premature delivery. The specific classification includes: A. extremely premature delivery, gestational age 28-32 weeks; B. early preterm birth, delivery gestational weeks 32-34 gestational weeks; C. late preterm birth, 34-36 gestational weeks.

② Secondary outcome measures: abortion, gestational diabetes mellitus, gestational hypertension, placental disorders, SGA / FGR, premature rupture of membranes, postpartum hemorrhage, mode of delivery, etc.

The follow-up contents were as follows

* Routine prenatal examination, blood pressure, fetal size, vaginal bleeding, etc.

* Coagulation factor index: prothrombin time Pt, activated partial thrombin time APTT, thrombin time TT, fibrinogen FIB, D-dimer

* Immune related indexes: antiphospholipid antibody, CA125 ④ Inflammatory index: routine blood test + CRP

* Detection of cervical length by B-ultrasound ⑥ Pregnancy complications: gestational diabetes mellitus, gestational hypertension and placental disorders ⑦ Birth outcome: gestational weeks, birth weight, FGR, premature delivery, mode of delivery, NICU rate, etc.

Conditions

  • Adenomyosis of Uterus

Interventions

DRUG

Aspirin/placebo

By using a random, double-blind research method, 1-550 digital computers are randomly divided into two groups, with two groups of digital coding placebo and aspirin. From 12 weeks of gestation, 100 mg of placebo or low-dose aspirin was given orally (2 tablets a time, twice a day, before going to bed) to 36 weeks of gestation.

Sponsors & Collaborators

  • Shanghai First Maternity and Infant Hospital

    lead OTHER

Principal Investigators

  • qiaoling Du, doctorate · Shanghai first maternal and infant hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-31
Primary Completion
2022-09-30
Completion
2022-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04535804 on ClinicalTrials.gov